TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT03860038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2025-04-24
Summary
This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.
Conditions
- Multiple Myeloma in Relapse
- Refractory Multiple Myeloma
Interventions
- DRUG
-
TJ202 and Dexamethasone
one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Sponsors & Collaborators
-
TJ Biopharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Lugui Qiu, Doctor · Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-28
- Primary Completion
- 2023-01-28
- Completion
- 2023-01-28
Countries
- China
- Taiwan
Study Locations
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